---
title: "Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B — FDA record Z-0323-2023 | Is It on Recall"
description: "Products were distributed in the United States without FDA authorization or clearance."
url: https://isitonrecall.com/recall/fda-device-z-0323-2023-dewei-dna-rna-preservation-kit-catalog-number-dw-80005-1b/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B — FDA record Z-0323-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- **Reason**: Products were distributed in the United States without FDA authorization or clearance.
- **Classification**: Class I
- **Recalling firm**: DEWEI MEDICAL EQUIPMENT CO LTD
- **Quantity**: 1,348,000 (US)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0323-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0323-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Distribution in states to: CA, FL, KY, and MI.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Michigan](https://isitonrecall.com/state/michigan/)

## Dates in the source

- **Report date**: Dec 14, 2022
- **Recall initiation date**: Aug 9, 2022
- **Center classification date**: Dec 7, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0323-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [DEWEI MEDICAL EQUIPMENT CO LTD records](https://isitonrecall.com/brand/dewei-medical-equipment-co-ltd/)